Drug companies have an obligation to inform the public about any harmful side effects of drugs they create and market. Unfortunately, sometimes the warning comes too late.
And in the case of the antipsychotic drug Abilify (aripiprazole), users say insufficient warning of the drug’s risks has cost them tens or hundreds of thousands of dollars, prompting them to file lawsuits against the drug’s maker, Otsuka Pharmaceutical, and its marketer, Bristol-Myers Squibb.
These lawsuits charge Otsuka and Bristol-Myers Squibb with being negligent in creating a drug that was defectively designed and manufactured. They also allege the company knew about Abilify’s alleged propensity for causing compulsive behavior, including compulsive gambling, and failed to provide adequate instructions and warning of its risks to the public.
Abilify users filed these lawsuits to:
- Cover expenses for treatment of compulsive gambling
- Recover money lost to gambling
- Gain compensation for severe emotional injuries
- Restore quality of life
Courts may also award punitive damages against manufacturers, which are intended to penalize defendants and ensure that neither they nor other organizations engage in similar behavior in the future.
Abilify Compulsive Behavior Claims
Doctors prescribe Abilify to treat mental disorders such as schizophrenia, bipolar disorder and major depression. They also prescribe the drug for off-label — or unapproved — uses, including anxiety disorders, dementia, eating disorders, insomnia, obsessive-compulsive disorder and post-traumatic stress disorder — though none of the off-label uses have undergone clinical trials to show efficacy or safety.
Scores of Abilify users claim use of the drug led to:
- Sexual urges
- Eating or binge eating
While the drug is effective at helping to control symptoms, it may come with a side effect that patients don’t expect: compulsive behavior. Prior to May 2016, Abilify’s label reported incidences of compulsive gambling, but it did “not entirely reflect the nature of the impulse-control risk [the agency] identified,” the FDA reported.
Post-marketing case reports suggest that Abilify users can experience intense urges and the inability to control these urges while taking the drug.
FDA Issues Abilify Warning, Lawsuits Grow
In May 2016, the FDA published a warning that compulsive or uncontrollable urges to gamble, binge eat, shop and have sex have been reported with the use of aripiprazole, and the number of lawsuits accusing Abilify of being responsible for compulsive gambling started to surge.
FDA Abilify Safety Communication
Between 2002 and 2016, the FDA identified 184 case reports in which there was an association between aripiprazole use and impulse-control problems. Of the compulsive behaviors, pathological gambling was the most common, with 164 cases. The number only includes reports submitted to the FDA; the agency noted that there could be additional cases about which it is not aware.
These compulsive behaviors can affect anyone who is taking the medicine, and, though rare, they may result in harm to the patient and others if not recognized, the FDA said in a May 3, 2016, Drug Safety Communication. As a result, the agency added new warnings in the drug’s label.
Within seven months of the FDA’s announcement, the number of Abilify gambling lawsuits had grown to more than 40.
Abilify Gambling Lawsuits
Plaintiffs who filed lawsuits against Bristol-Myers Squibb and Otsuka said the drug turned them into compulsive gamblers and sex addicts and ruined their lives. Among those who filed lawsuits are:
In April 2016, Joseph Edgar filed suit, alleging that he began to gamble compulsively after he began taking Abilify in April 2009. The gambling problems stopped after he stopped taking the drug in April 2014, but he had lost more than $36,000 and faced other mental and physical damages.
A day after Edgar filed suit in Pennsylvania, a woman named Athalean Harper-Mosley filed a similar suit in California. She claims she began taking Abilify in July 2007, incurred gambling losses of more than $65,000 and stopped having impulsivity problems after she stopped taking the drug in May 2014.
Patrick Parks sued the drug’s makers in November 2016. Parks began taking the drug around May 2013 and “began compulsively gambling shortly thereafter,” his complaint says. He stopped taking Abilify in August 2014 and stopped gambling. But by then he had already lost more than $75,000.
Similarly, Massachusetts resident Rikki Carlson sued Bristol-Meyers Squibb, Otsuka Pharmaceutical and Otsuka American Pharmaceutical alleging that after she began taking Abilify in December 2010, she began compulsively gambling, eating and shopping. Those behaviors stopped after she stopped taking the medication in March 2016.
Abilify Multidistrict Litigation
In October 2016, the U.S. Judicial Panel on Multidistrict Litigation consolidated 22 federal Abilify lawsuits filed in 12 districts into a multidistrict litigation (MDL) and transferred the MDL to the U.S. District Court, Northern District of Florida.
The panel commonly takes this step when many federal lawsuits share similar characteristics. The judge presiding over the MDL and the parties involved then choose one or more representative cases, called bellwether cases, and the results of those trials help the remaining plaintiffs and defendants decide how to proceed.
“Plaintiffs in these actions each allege that they experienced compulsive gambling behaviors as a result of taking Abilify,” the panel said in its transfer order. “All the actions involve factual questions relating to whether Abilify was defectively designed or manufactured, whether defendants knew or should have known of the alleged propensity of Abilify to cause compulsive gambling behaviors in users, and whether defendants provided adequate instructions and warnings with this product.”
Status of Abilify MDL
As of March 2017, 60 actions were pending under the MDL. The case, officially designated MDL 2734, in re: Abilify Products Liability Litigation, was in the discovery period, an early phase of the process.
U.S. District Judge M. Casey Rodgers is presiding over the pretrial proceedings and has detailed a rigid schedule. It calls for a few cases to be prepared for bellwether trials.
The bellwether trial process may lead to potential Abilify settlements to resolve a numbers of the cases.
Abilify MDL Settlements
Judge Rodgers appointed experienced legal mediator and negotiator Cathy Yanni as the settlement master on Feb. 28, 2017. Yanni was involved in similar drug and medical device litigation, including transvaginal mesh, the Medtronic Infuse, Avandia heart attacks and Yaz birth control lawsuits.
The next day, Judge Rodgers instructed plaintiffs and Otsuka Pharmaceuticals to meet for a settlement conference with Yanni. No settlements have been announced in the cases pending under the MDL.
Other Abilify Litigation
Type 2 Diabetes Claims
Five women sued Bristol-Myers Squibb Co. and Otsuka American Pharmaceutical in 2014 and 2015, alleging Abilify caused type 2 diabetes in minor children and that the companies failed to warn physicians who prescribed the drug for off-label use of that risk. Those suits, however, were dismissed. They were all filed in New York, and the defendants successfully argued that they would be unable to get out-of-state witnesses to testify.
A U.S. judge tossed federal-court claims that Bristol-Myers Squibb and Otsuka Pharmaceutical paid kickbacks to persuade doctors to prescribe Abilify. Two whistleblowers brought the lawsuit in 2011, pointing to promotions to pediatric psychiatrists as evidence of off-label marketing. Judge William Bertelsman said in his ruling that there was a lack of specific evidence to support the kickback claims. He did, however, permit the whistleblowers to pursue claims that Bristol-Myers fired them to retaliate for their off-label accusations.
Illegal Promotion of Abilify
It is not illegal for doctors to prescribe a medication for an unapproved use, but it is illegal for drug companies to encourage doctors to do it. Bristol-Myers Squibb has paid two multimillion-dollar settlements to resolve allegations that it did just that.
$515 Million Settlement
The U.S. Department of Justice brought a lawsuit against Bristol-Myers Squibb, accusing the company of promoting Abilify for pediatric use and to treat dementia-related psychosis — both off-label uses.
In 2007, the company paid $515 million to settle federal charges of illegal marketing, including marketing Abilify for off-label use.
The government alleged that, from 2002 to 2005, the company marketed Abilify to nursing homes for use for dementia-related psychosis. Abilify is not FDA-approved for treatment of dementia. In fact, the drug’s label contains a black box warning, the FDA’s strongest warning, stating that elderly patients with dementia-related psychosis who are treated with antipsychotic drugs have an increased risk of death.
The government also claimed Bristol-Myers Squibb sent its sales force to promote the drug to child psychiatrists and other pediatric specialists.
$19.5 Million Settlement
Nearly a decade later, Bristol-Myers Squibb settled a different case over the same practices alleged in the 2007 federal suit— this time with state governments.
The states initiated a consumer-protection investigation in 2009 targeting Otsuka Pharmaceutical and Bristol-Myers Squibb. In December 2016, the company agreed to pay a $19.5 million settlement to 42 states and the District of Columbia to resolve claims it engaged in unfair or deceptive trade practices when marketing Abilify.
Under the settlement, the company can’t make “false or misleading claims” about Abilify or misrepresent findings of clinical studies about the drug.
States sharing the Abilify settlement include: Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Vermont, Washington, West Virginia, and Wisconsin.
State Attorneys General React
“These companies endangered and compromised the health and well-being of millions of Americans in order to turn a profit.”
- Then California Attorney General Kamala D. Harris
“Despite receiving a ‘black box’ warning stating that elderly patients with dementia-related psychosis who are treated with antipsychotic drugs have an increased risk of death, the promotion of Abilify to elderly patients was not halted.”
- Nevada Attorney General Adam Paul Laxalt
“With this multistate settlement, consumers will be armed with better information about medication that could endanger their health.”
- Florida Attorney General Pam Bondi